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Phase IV Study to Compare Efficacy and Safety of Plavix 75mg With Astrix 100mg and Closone

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01765452
First Posted: January 10, 2013
Last Update Posted: May 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CJ HealthCare Corporation
  Purpose
The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of Plavix with Astrix.

Condition Intervention Phase
Coronary Artery Disease Drug: Closone Drug: Plavix with Astrix Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center, Randomized, Open Study for Comparison of Efficacy and Safety of Plavix With Astrix and Closone in Patients With Post-Percutaneous Coronary Artery Intervention

Resource links provided by NLM:


Further study details as provided by CJ HealthCare Corporation:

Primary Outcome Measures:
  • Change from baselinine in P2Y12% inhibition at week 8 [ Time Frame: Baseline, week 8 ]

Secondary Outcome Measures:
  • Change from baseline in PRU, ARU at week 8 [ Time Frame: Baseline, week 8 ]

Enrollment: 285
Study Start Date: October 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Closone
75mg/100mg per day, 8weeks, PO
Drug: Closone
75mg/100mg, 8weeks, PO
Active Comparator: Plavix with Astrix
75mg per day, 8weeks, PO 100mg per day, 8weeks, PO
Drug: Plavix with Astrix
75mg, 100mg a day, 8weeks, PO

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects under a stable condition after Post-Percutaneous Coronary Artery Intervention over three months
  • 20~86 years old
  • Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

  • Subject who did not undergo or failed Drug-Stent Implantation
  • Subjects who took an anti-coagulant, anti-thrombotic regularlly( ≥ 2weeks in a month) before the study, or plan to have continuous treatment during the study(Except Aspirin alone or combination of Aspirin and Clopidogrel)
  • Subjects with a history of substance or alchol abuse
  • Subjects with a history of hypersensitivity to Clopidogrel, Aspirin or other NSAIDS
  • Subjects having Aspirin or other NSAIDs-induced Asthma or history
  • Subjects with Severe hepatopathy(AST and ALT > 5 times the upper limit of normal)
  • Subjects with Severe nephropathy(Cr > 3 times the upper limit of normal)
  • Subjects with hemorrhage like gastric ulcer, intracranial hemorrhage etc.
  • Subjects with high risk of hemorrhage like blood coagulation disorders, uncontrolled severe hypertension, active bleeding, history of severe bleeding
  • subjects who are pregnant, breastfeeding
  • Subjects not using medically acceptable birth control
  • Subjects who are unsuitable to take the Investigational product due to a medical/mental condition
  • Subjects inherently having Galactose malobsorption, Lactase deficiency or Glucose-Galactose malobsorption
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765452


Locations
Korea, Republic of
Inje university haeundae paik hospital
Busan, Korea, Republic of
Kosin university gospel hospital
Busan, Korea, Republic of
Pusan national university hospital
Busan, Korea, Republic of
Chungbuk national university hospital
Chungbuk, Korea, Republic of
Dongguk University Medical Center
Gyeonggi-do, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
SNU Boramae Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
CJ HealthCare Corporation
  More Information

Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT01765452     History of Changes
Other Study ID Numbers: CJ_CLO_401
First Submitted: January 7, 2013
First Posted: January 10, 2013
Last Update Posted: May 12, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs